DefinePK

Abstract

Background: Off-label prescribing, the use of pharmaceutical drugs beyond their approved indications, is a growing practice globally and raises important questions regarding safety, efficacy, and regulatory oversight. Despite its widespread application in various specialties, many healthcare providers remain unaware of the legal and ethical implications of such use. In countries like Pakistan, where formal regulations are lacking, assessing physician knowledge and behavior becomes crucial to ensure patient safety and informed clinical decision-making.
Objective: To evaluate the knowledge, attitude, and practice (KAP) of physicians in Pakistan regarding off-label drug use and identify gaps requiring policy and educational interventions.
Methods: This cross-sectional study employed a self-developed, pre-validated questionnaire distributed to 377 MBBS-qualified physicians across various hospitals in Islamabad and Rawalpindi between December 2023 and May 2024. A total of 210 valid responses were collected (response rate: 56%). The questionnaire comprised demographic data and 20 knowledge and experience-based items. Data were analyzed using SPSS version 25. Categorical variables were summarized in frequencies and percentages, and continuous variables were presented as means ± standard deviations. Fisher’s exact test and chi-square test were used to assess associations, with p ≤ 0.05 considered statistically significant.
Results: Among the respondents, 55.7% were male and 44.3% were female; 83% were specialists and 17% were general practitioners. While 80% were familiar with the concept of off-label prescribing, only 21% correctly defined it. A total of 55.8% had prescribed off-label medications, yet 45.7% believed they had never done so, reflecting a knowledge gap. Moreover, 58% perceived off-label use as illegal, and 86.7% recommended the need for formal guidelines. Mean KAP scores were moderate across all domains, with significant differences based on gender, specialty, and experience (p<0.05).
Conclusion: Physicians in Pakistan demonstrate moderate understanding and limited experience regarding off-label prescribing. The findings highlight an urgent need for regulatory frameworks and targeted education to ensure evidence-based and safe off-label drug use.